Jack O’Shaughnessy – Changing Regulations in the European Union: How does it impact your business?

The European Union faces a substantial PFAS problem, with multiple regulations being proposed, including proposed restrictions placed on the entire PFAS family (over 10,000 PFAS substances) within six EU member states. In light of the proposed restrictions, EU businesses must prepare for impending regulatory changes and how they may impact their organisations. Jack O’Shaughnessy, EU Commercial Lead- Emerging Contaminants at Tetra Tech offers crucial expertise in navigating evolving PFAS regulations to ensure companies adapt effectively, comply with standards, and mitigate the effects on their operations in this era of heightened environmental scrutiny.

What is PFAS and what effects can they have on people?

Per- and Polyfluoroalkyl Substances (PFAS) are a class of thousands synthetic chemicals renowned for their unique properties, including water and grease resistance, high heat resistance, and chemical stability. PFAS have been found in a wide range of industrial and consumer products due to their hydrophobic and stable properties, including but not limited to:

  • Firefighting foams
  • Non-stick cookware
  • Waterproof clothing
  • Food packaging
  • Cosmetics

However, concerns have been raised over the toxicity, mobility, bioaccumulation, and persistence of PFAS in the environment and their potential adverse effects on human health. PFAS are commonly referred to as “persistent chemicals” because they resist degradation and remain in ecosystems for long periods of time.

Exposure to PFAS can lead to various health impacts in individuals including elevated cholesterol, cancer, liver damage, immunosuppression, and reproductive concerns.

The persistent presence of PFAS in the environment results in the gradual accumulation of higher concentrations, increasing the potential exposure risks for humans and other species. Exposure can occur through the contamination of groundwater and drinking water. The remediation of PFAS-contaminated areas is a complex task that requires specialized technical knowledge and remediation techniques.

Additionally, certain PFAS tend to accumulate in plants, animals, and humans, leading to detrimental effects on human health, such as reproductive problems, carcinogenicity, and suspected endocrine disruption.

What common products contain PFAS?

PFAS are commonly found in various consumer and industrial products due to their distinctive properties, including food packaging, waterproof clothing, stain-resistant products, fire-fighting foams, cleaning products, and electronics.

 What impacts have PFAS had?

The manufacture and use of PFAS has resulted in severe contamination of soil, groundwater, surface water, and food across the EU. More than 17,000 PFAS-impacted sites have been identified across the EU, with another 21,000 presumed to be contaminated. This has resulted in harmful exposure to humans.

It is estimated that within the EU, between 140,000 and 310,000 tonnes of PFAS material were introduced into various markets in 2020. The estimated health cost as a result of exposure to PFAS in the EU is between €52 and €84 billion. An estimated 84,000 to 273,000 workers in the EU are at risk of exposure to PFAS (Göckener et al., 2020).

PFAS are chemicals that pollute groundwater, surface water, soil, and sediments. They cause a diverse range of health implications for humans and animals and are complicated and expensive to clean up. Some PFAS are toxic to the reproduction and development of fetuses. Others are thought to be linked to cancer, thyroid issues, increased cholesterol levels in humans, and hormone interference.

What current and future PFAS legislation change should companies be aware of?

Current Regulation

Current EU legislation enforced under The European Chemicals Agency (ECHA) restricts the use of perfluorooctanoic acid (PFOA) , total perfluorooctane sulfonate (PFOS), perfluorohexane sulfonic acid (PFHxS), and the sum of perfluorocarboxylic acids (PFCAs) and their precursors (ECHA Website). The restriction applies to the manufacture, import, and use of these PFAS compounds within the EU market.

PFAS thresholds for drinking water and surface water are regulated under the EU Drinking Water Directive (2020/2184/EU) across Europe. Drinking water criteria were recently established in January 2021, with a limit of 0.1 µg/l for the sum of PFAS and 0.5 µg/l for total PFAS. The directive requires member states to monitor PFAS levels and to take measures when PFAS levels exceed the limits. In addition to the EU Drinking Water Directive, several EU member states have also implemented their own national regulations on PFAS in drinking water. These regulations vary from country to country, but they all set stricter limits on PFAS concentrations in drinking water than the EU-wide Maximum Permissible Level (MPL).

Similarly, fresh water Environmental Quality Standards (EQSs) were established by the European Union for PFOS and PFOA and their derivatives to protect human health and the environment. An EQS of 0.00065 µg/l is in place for inland surface waters and all other surface waters have an EQS of 0.00013 µg/l.

Proposed Restrictions in The EU

A universal PFAS ban has been proposed to restrict and limit PFAS manufacturing and use within Europe in an attempt to ultimately reduce PFAS emissions to the environment. The proposal was prepared by five national authorities (the Netherlands, Germany, Sweden, Norway, and Denmark) and submitted on January 13, 2023. It aims to regulate the production, import, and use of PFAS, including their presence as components in other substances, mixtures, and articles, within Europe. The proposal’s scope is extensive, encompassing over 10,000 PFAS substances, and it offers two potential restriction options:

  • Restriction Option 1 entails a complete ban of PFAS (OECD, 2018 definition) after an 18-month transition period.
  • Restriction Option 2 would implement a phased ban in specific cases while allowing for time-restricted derogations for uses. Additionally, the proposal includes time-unlimited derogations in exceptional circumstances.

ECHA scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) have approved the proposal and it is now out for public consultation. The final decision of the proposed restrictions is expected in 2024.

Germany has also proposed national restrictions for perfluorohexanoic acid (PFHxA) and its precursors. The RAC and SEAC support the proposal, with minor concerns about PFHxA in paper, cardboard, and food contact materials where minimising the compound is not possible. The finalisation of the proposed restriction has not yet been announced.

The European Chemicals Agency (ECHA) has proposed an EU-wide restriction on PFAS firefighting foams. The proposed restriction bans the placement of PFAS compounds on the market with dedicated sector-specific transition periods. This action comes in response to the Commission’s directive to assess the environmental and health hazards associated with the use of PFAS-based firefighting foams. The restriction is anticipated to reduce PFAS emissions into the environment by approximately 13,200 tonnes over a 30-year period.

ECHA’s RAC supports the proposed restriction of PFAS in firefighting foams (March 2023). ECHA’s Committee for Socio-Economic Analysis (SEAC) has also recently provided an opinion supporting the gradual ban on PFAS substances in firefighting foam. SEAC has highlighted multiple concerns, including the availability of fluorine-free foam alternatives, the treatment and storage of PFAS substances, viability of offshore installations to transition, and transition periods. The proposed restriction is anticipated to come into force in 2024.

On October 26, 2022, the EU Commission published its Proposal for a Directive to amend the Water Framework Directive (WFD, Directive 2000/60), the Groundwater Directive (GWD, Directive 2006/118/EC), and the Environmental Quality Standards (EQSD, Directive 2008/105/EC). The objective of the Directive is to further protect human and environmental health from toxic and/or persistent pollutants. The proposed updates will increase the number of priority substances for surface water and groundwater (including PFAS) as well as their associated thresholds. These thresholds will then be used to assess the chemical status of water under the WFD. The proposed amendments also include new monitoring and reporting requirements.

How can companies prepare for the upcoming PFAS restriction?

To prepare for the forthcoming PFAS restriction, companies can adopt several proactive strategies to ensure compliance and mitigate the impact on their operations. These Include:

  • Evaluate PFAS Usage/Risk Assessment: Companies should identify and assess all products, processes, and materials used that contain PFAS. Understanding the extent of PFAS use within the company is crucial for devising appropriate measures.
  • Stay Compliant with Regulations: Stay up-to-date with the latest regulatory developments concerning PFAS restrictions. Complying with existing and forthcoming regulations is essential to avoid penalties and protect your company’s reputation (ECHA Website, Proposal for a Directive). Consider how the proposed regulations might impact your business. Companies should also review their current water use and discharge permits ensuring they are compliant with the new EQS.
  • Transition to PFAS-Free Alternatives: Companies should explore and invest in alternative materials and chemicals that do not contain PFAS. This may entail research and development to find suitable replacements for current PFAS-containing products. Plan for the cost implications, supply chain concerns when transitioning to PFAS free alternatives.
  • Implement Proper Waste Management: Adopt sound waste management when disposing of PFAS impacted material. Ensuring proper disposal methods for PFAS-related waste is crucial.
  • Monitor Environmental Impact: Regularly monitor your company’s environmental impact related to PFAS. This practice helps identify potential contamination issues and allows for timely corrective actions.
  • Engage with Experts: Engage with expert consultants to facilitate discussions with relevant regulatory authorities to understand the specific requirements of the forthcoming restrictions and seek clarifications if necessary.

What services does Tetra Tech offer that can help mitigate PFAS effects?

Tetra Tech provides a crucial role in assisting companies in preparing for regulatory changes related to PFAS. As regulations concerning PFAS substances continue to evolve and grow more intricate, Tetra Tech can offer essential expertise, guidance, and assistance to make sure compliance and mitigate the effects of regulatory changes on your business. Tetra Tech can offer the following proficiencies:

  • Regulatory Knowledge: Key understanding on the latest developments in PFAS regulations at the national, regional, and international levels. Tetra Tech has a deep understanding of the specific requirements and restrictions that may apply to PFAS substances in various industries and applications.
  • Impact Assessment: Tetra Tech can conduct thorough assessments of how the upcoming PFAS regulatory changes will affect a company’s products, processes, and operations. Tetra Tech can analyse the potential risks and opportunities arising from the new and future regulations.
  • Compliance Strategies: Based on the regulatory expertise, Tetra Tech can develop tailored compliance strategies for companies. These strategies may include identifying alternative PFAS-free materials, reviewing supply chains, and establishing best practices for waste management.
  • Training and Education: Tetra Tech can provide training sessions for employees to raise awareness of the upcoming PFAS regulatory changes and their implications. Educating staff can smooth the transition to new practices and fosters a culture of compliance.
  • Risk Management: we can assist you by developing risk management strategies to address potential liabilities associated with PFAS compliance and make sure the company’s reputation remains intact.

Tetra Tech has a proven track record of providing PFAS expertise and technical advice, across UK, EU, Oceania and North America and across multiple sectors. Tetra Tech is currently working with a range of clients across multiple sectors providing technical advice in accordance with the shifting regulations with particular focus on PFAS containing AFFF. In light of recent regulations within the US Tetra Tech has recently been commissions to deliver foam transitional services on behalf of U.S Army Engineering valued at $800 million USD. With consistently changing regulations across EU it is important that organisation understand their requirements and liabilities when manufacturing, importing or transporting PFAS containing material.

For more information contact Jack at: [email protected]

Want to get in touch?